Press releases

STOCKHOLM — October 26, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces data from the phase 3 LIGHTHOUSE study that further confirms the clinical benefit of melflufen in patients with relapsed refractory multiple myeloma (RRMM). The LIGHTHOUSE study investigated the efficacy and safety of the combination of melflufen plus daratumumab subcutaneous (sc) plus dexamethasone in comparison with daratumumab sc. (with supportive dexamethasone) in patients who were refractory to at least an immunomodulatory agent and a proteasome inhibitor or have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent

STOCKHOLM — October 20, 2022 — The Board of Directors of Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) (“Oncopeptides”), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, has today resolved, by virtue of the authorization by the Annual General Meeting held on June 28, 2022, to issue and immediately thereafter re-purchase a total of 3,940,607 class C shares. The shares are issued and re-purchased in accordance with the shareholder program and the incentive program which were adopted by the Annual General Meeting held on June 28, 2022 (“Board SHP 2022” and “Co-worker LTIP 2022” respectively)

STOCKHOLM — October 3, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Company has submitted the AMNOG dossier to “The Federal Joint Committee” (G-BA) in Germany. This initiates the commercial launch of Pepaxti[®] (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched

Stockholm, Sweden – An Extraordinary General Meeting in Oncopeptides AB (publ) (ONCO) was held on Friday, 23 September 2022. At the Extraordinary General Meeting, the following principal resolution was passed

STOCKHOLM — September 23, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Oncologic Drugs Advisory Committee (ODAC), of the US Food and Drug Administration (FDA), has finalized the discussion on the benefit-risk profile of Pepaxto[®] (melphalan flufenamide, also called melflufen). A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population. Pepaxto is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody

STOCKHOLM — September 20, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration (FDA), has published the Briefing Book for the Oncologic Drugs Advisory Committee (ODAC) meeting on September 22, 2022. The purpose of the meeting is to obtain the advisory committee´s input regarding the benefit/risk of Pepaxto[®] (melphalan flufenamide, also called melflufen) for the currently indicated patient population

STOCKHOLM — September 7, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the company has received a research grant of 5 MSEK from Sweden´s Innovation Agency, to develop preclinical proof of concept (PoC) for a novel synthetic small polypeptide for the treatment of multiple myeloma. The compound is a Natural Killer (NK) cell engaging immunotherapy, with superior tissue penetration and immune cell activation. The NK ENGAGE project has been qualified as a Eurostars program and will be driven by a research consortium including the department of Cancer Immunology at Oslo University Hospital, Norway, Pharmatest Services Ltd in Turku, Finland, and Oncopeptides, together with its collaborator the Royal Institute of Technology in Stockholm, KTH, where the technology originally stems from

The shareholders in Oncopeptides AB (publ), reg. no. 556596-6438, with registered office in the municipality of Stockholm, (“Oncopeptides” or the “Company”) are hereby given notice to attend the Extraordinary General Meeting to be held on Friday 23 September 2022

STOCKHOLM — August 18, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the European Commission has granted Pepaxti[®] (melphalan flufenamide, also called melflufen) marketing authorization in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. The marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway

STOCKHOLM — August 11, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today publishes the report for the second quarter 2022